First Group of Subjects Dosed with Innovator Drug for Gout FCN-207 Tablets of Fochon Pharmaceuticals, Ltd.
On November 11, 2020, the first group of subjects in the Phase I clinical study of a selective URAT1 inhibitor, FCN-207 Tablets, independently developed by Chongqing Fochon Pharmaceuticals Ltd. (hereinafter referred to as "Fochon Pharmaceuticals") was administered in Peking University Third Hospital.
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending doses (SAD and MAD) Phase I clinical study to evaluate the safety, tolerability, PK/PD profiles of FCN-207 tablets and food effect in healthy subjects.
About FCN-207 Tablets
Market for Gout and Hyperuricemia Drugs
Statistics have shown that there are more than 200 million hyperuricemia patients and more than 55 million gout patients worldwide. There are 50 million hyperuricemia patients and 8.3 million gout patients in the United States. The incidence of hyperuricemia in China is relatively high, reaching more than 10%, which is far beyond the global incidence of 0.2%-0.35%. The number of hyperuricemia patients also reaches 170 million, including more than 80 million gout patients.
The development of more effective and safer drugs for hyperuricemia is an urgent clinical need, which will surely bring huge social and economic benefits.
About Fochon Pharmaceuticals
Chongqing Fochon Pharmaceuticals Ltd., jointly established by a group of overseas scientists with Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and its member enterprises in 2009, is a high-tech enterprise committed to the research and development of first-in-class small-molecule targeted drugs with proprietary intellectual property rights. It is an innovation-driven and efficient operation with bases in "two countries and three regions" in Chongqing, Shanghai and San Francisco Bay Area, and continuously pursues excellence with Chinese power grafted to global resources. The eternal mission of Fochon Pharmaceuticals is to benefit global patients with high-quality new drugs.
Focusing on the research of innovator drugs for anti-tumor and metabolic diseases urgently needed in clinical practice, Fochon Pharmaceuticals has successfully pushed 9 projects into the clinical studies, including 1 project in Phase III clinical study, 3 projects in Phase II clinical studies, and 5 projects in Phase I clinical studies, meanwhile, there are another 6-7 projects in preclinical studies.
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending doses (SAD and MAD) Phase I clinical study to evaluate the safety, tolerability, PK/PD profiles of FCN-207 tablets and food effect in healthy subjects.
FCN-207 is a high-affinity selective inhibitor of the uric acid transporter 1 (URAT1) that inhibits the reabsorption of uric acid by inhibiting the activity of proximal tubular URAT1 in the kidney, thereby reducing serum uric acid levels.
Market for Gout and Hyperuricemia Drugs
Statistics have shown that there are more than 200 million hyperuricemia patients and more than 55 million gout patients worldwide. There are 50 million hyperuricemia patients and 8.3 million gout patients in the United States. The incidence of hyperuricemia in China is relatively high, reaching more than 10%, which is far beyond the global incidence of 0.2%-0.35%. The number of hyperuricemia patients also reaches 170 million, including more than 80 million gout patients.
The development of more effective and safer drugs for hyperuricemia is an urgent clinical need, which will surely bring huge social and economic benefits.
About Fochon Pharmaceuticals
Chongqing Fochon Pharmaceuticals Ltd., jointly established by a group of overseas scientists with Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and its member enterprises in 2009, is a high-tech enterprise committed to the research and development of first-in-class small-molecule targeted drugs with proprietary intellectual property rights. It is an innovation-driven and efficient operation with bases in "two countries and three regions" in Chongqing, Shanghai and San Francisco Bay Area, and continuously pursues excellence with Chinese power grafted to global resources. The eternal mission of Fochon Pharmaceuticals is to benefit global patients with high-quality new drugs.
Focusing on the research of innovator drugs for anti-tumor and metabolic diseases urgently needed in clinical practice, Fochon Pharmaceuticals has successfully pushed 9 projects into the clinical studies, including 1 project in Phase III clinical study, 3 projects in Phase II clinical studies, and 5 projects in Phase I clinical studies, meanwhile, there are another 6-7 projects in preclinical studies.